ASCO 2013: Transformative trial for non-Hodgkin lymphoma patients
June 2, 2013 | by Roberta Nichols
Patients with transformed non-Hodgkin lymphoma (NHL) – in which low-grade lymphoma mutates into diffuse large cell lymphoma – have a poor prognosis, generally surviving only about seven to 20 months.
Those odds now look considerably more promising thanks to a novel conditioning regimen combining radioimmunotherapy (which uses monoclonal antibodies to deliver radiation to the tumor), high-dose chemotherapy and autologous stem cell transplantation, in which the patient’s own stem cells are removed, cleansed and reinfused.
City of Hope has collaborated with a center in the Netherlands and a center in Israel to combine the results of such a treatment approach for transformed NHL; their findings are being presented at a poster session at the American Society of Clinical Oncology meeting in Chicago, May 31 through June 4.
Previous studies demonstrated that patients with transformed non-Hodgkin lymphoma were helped by high-dose chemotherapy and autologous stem cell transplantation.
“In this study we looked at our outcomes with patients with transformed lymphoma getting Zevalin Beam conditioning. It was well tolerated, there was low toxicity and they had good overall survival – 90 percent at two years,” said first author Amrita Krishnan, M.D., director of the Multiple Myeloma Program at City of Hope. “Our multicenter experience with radioimmunotherapy-based conditioning plus high-dose chemotherapy demonstrated the safety and efficacy of the regimen in diffuse large cell lymphoma,” she said.
The study combines the data from the experiences of 57 patients treated at different centers between 2003 and 2011 with this regimen. Twenty from City of Hope, six from Israel and 31 from the Netherlands. All had low-grade non-Hodgkin lymphoma that transformed into diffuse large cell lymphoma. The ages of the patients in the trial ranged from 41 to 69, with a median age of 59.6.
Since it took eight years to accrue the 57 patients, said Krishnan, “I don’t think we’re ever going to get to a phase III trial just for transformed lymphoma. Yet, these results suggest that this treatment is a very viable option for these patients,” she added. “It’s a well-tolerated regimen that leads to good overall survival for this relatively rare disease.”
Krishnan said that the results with this conditioning regimen were so promising that she and her Israeli and Dutch colleagues are planning a new expanded collaboration – a phase III randomized clinical trial focusing exclusively on diffuse large cell lymphoma patients.
Expected to open later this summer, the trial will accrue patients from City of Hope and other U.S. hospitals, as well as from Israel, the Netherlands, Germany and France. Krishnan said researchers hope to enroll 182 patients for this international collaboration. This trial will be listed on clinical trials.gov and the City of Hope website.